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Continuous Blood Pressure Variability and Small Vessel Disease in Acute Ischemic Stroke (COMPASS)

6. November 2026 aktualisiert von: Minyoul Baik

Continuous Outcome Modeling by Pressure Variability and Small Vessel Status in Acute Ischemic Stroke: A Prospective Observational Cohort Study (COMPASS)

This prospective observational cohort study examines whether blood pressure variability and nighttime blood pressure patterns, measured non-invasively over 72 hours with a cuffless ring-type wearable device, help predict recovery in patients with acute ischemic stroke.

In acute ischemic stroke, how much blood pressure fluctuates - and whether it drops normally during sleep - may affect brain injury and outcome. Standard cuff monitors measure blood pressure only intermittently and can disturb sleep, which limits assessment of these patterns. This study uses a finger-worn cuffless continuous monitor to capture blood pressure without disturbing sleep.

The study also examines whether the burden of pre-existing cerebral small vessel disease, seen as white matter changes on brain MRI, changes how strongly blood pressure variability relates to outcome.

Blood pressure data are collected for research analysis only and are not used to guide treatment. All clinical care follows standard stroke guidelines, regardless of study participation. The main outcome is functional recovery (modified Rankin Scale) at hospital discharge.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Design and population: This is a single-center, prospective, observational cohort study. Adults (>=19 years) with acute ischemic stroke presenting within 24 hours of symptom onset are enrolled. Patients with atrial fibrillation are excluded because it degrades the accuracy of photoplethysmography (PPG)-based blood pressure estimation. A total of 450 participants are planned over three years.

Blood pressure monitoring: As soon as possible after enrollment, a cuffless, PPG-based ring-type wearable device is applied to a finger and records blood pressure continuously for up to 72 hours without disturbing sleep. Wearing the device does not interfere with standard care, and blood pressure management follows standard clinical guidelines. The device data are used for research analysis only and do not guide real-time treatment.

Imaging: Baseline white matter hyperintensity (WMH) is graded on MRI FLAIR using the Fazekas scale (total 0-6), with severe WMH defined as a total score of 3 or higher.

Exposures: The primary exposure is systolic blood pressure variability over the first 72 hours (primary metric: standard deviation of systolic blood pressure). Secondary exposures include the coefficient of variation and maximum-minimum difference of systolic and diastolic blood pressure, and the nocturnal dipping pattern (dipper, non-dipper, reverse-dipper).

Outcome: The primary outcome is poor functional outcome, defined as a modified Rankin Scale score of 3-6, assessed at hospital discharge.

Hypotheses: (1) Increased systolic blood pressure variability and a nocturnal non-dipping pattern independently predict poor functional outcome at discharge. (2) Severe WMH amplifies the association between blood pressure variability and poor outcome (synergistic effect).

Statistical analysis: The primary analysis uses multivariable logistic regression relating systolic blood pressure variability (standard deviation) to poor outcome (mRS 3-6), adjusted for mean blood pressure, age, sex, baseline comorbidities, and initial NIHSS. Incremental model performance is assessed by AUC, net reclassification improvement (NRI), and integrated discrimination improvement (IDI).

A prespecified interaction analysis tests effect modification by severe WMH (blood pressure variability x severe WMH; P for interaction), with subgroup analysis by WMH severity (Fazekas >=3 vs <3).

Prespecified secondary analyses re-examine the primary finding using alternative variability metrics and the nocturnal dipping pattern.

Prespecified exploratory analyses include nonlinear dose-response modeling of blood pressure variability and mean blood pressure using restricted cubic splines, including spline curves stratified by WMH severity. Analyses beyond those prespecified are reported as exploratory.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

450

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Südkorea
    • Gyeonggi-do
      • Yongin, Gyeonggi-do, Südkorea, 16995
        • Rekrutierung
        • Yongin Severance Hospital, Yonsei University College of Medicine
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

19 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Adults with acute ischemic stroke presenting within 24 hours of symptom onset and admitted to a single stroke center. Patients with atrial fibrillation are excluded because it degrades the accuracy of photoplethysmography-based blood pressure estimation.

Beschreibung

Inclusion Criteria:

  • Adults aged 19 years or older
  • Acute ischemic stroke confirmed on diagnostic imaging, presenting within 24 hours of symptom onset
  • Written informed consent from the patient or, if the patient is temporarily unable to consent, a legally authorized representative (with patient re-consent upon recovery)

Exclusion Criteria:

  • Atrial fibrillation or other arrhythmia that degrades the accuracy of photoplethysmography-based blood pressure estimation
  • Finger condition unsuitable for device wear (injury, edema, circulatory compromise, or amputation)
  • Short life expectancy or imminent death making 72-hour observation inappropriate
  • Other conditions deemed unsuitable for the study by the investigator

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: COHORT
  • Zeitperspektiven: PROSPECTIVE

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Acute ischemic stroke with 72-hour continuous BP monitoring

Adults with acute ischemic stroke presenting within 24 hours of onset who undergo up to 72 hours of cuffless continuous blood pressure monitoring with a ring-type wearable device. Analyzed as a single cohort with blood pressure variability as a continuous exposure; a prespecified subgroup is defined by white matter hyperintensity severity (Fazekas total >=3 vs <3).
Gerät: Cuffless ring-type continuous blood pressure monitor

A cuffless, photoplethysmography-based ring-type wearable device worn on a finger records blood pressure continuously for up to 72 hours after admission for acute ischemic stroke. It is used solely for observational research data collection and does not guide clinical treatment; blood pressure management follows standard care regardless of the device readings. Blood pressure variability metrics derived from these recordings are the exposure of interest.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Poor functional outcome (modified Rankin Scale 3-6) at discharge
Zeitfenster: At discharge or transfer from the neurology service, whichever occurs first (an average of 7 days)

Functional outcome measured by the modified Rankin Scale (mRS), a 7-level scale from 0 (no symptoms) to 6 (death). Poor outcome is defined as mRS 3-6 versus good outcome mRS 0-2, assessed at hospital discharge. The primary analysis relates this outcome to systolic blood pressure variability (standard deviation) over the first 72 hours.
At discharge or transfer from the neurology service, whichever occurs first (an average of 7 days)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Ordinal modified Rankin Scale at the end of admission
Zeitfenster: At discharge or transfer from the neurology service, whichever occurs first (an average of 7 days)

Full distribution of the modified Rankin Scale (0-6) at the end of the acute neurology admission, analyzed in relation to blood pressure variability metrics.
At discharge or transfer from the neurology service, whichever occurs first (an average of 7 days)
Early neurological deterioration during hospitalization
Zeitfenster: During the acute neurology admission (an average of 7 days)

Early neurological deterioration, defined as an increase of 2 or more points in the NIHSS during the acute admission.
During the acute neurology admission (an average of 7 days)
Parenchymal hematoma during hospitalization
Zeitfenster: During the acute neurology admission (an average of 7 days)

Parenchymal hematoma on follow-up imaging, classified by the ECASS radiologic criteria (PH1 or PH2), during the acute neurology admission.
During the acute neurology admission (an average of 7 days)
Poor functional outcome (modified Rankin Scale 3-6) at 3 months
Zeitfenster: 90 days after stroke onset

Functional outcome is measured by the modified Rankin Scale (mRS), a 7-level scale ranging from 0 (no symptoms) to 6 (death). A poor outcome is defined as an mRS score of 3-6, compared to a good outcome of 0-2, evaluated at 3 months post-stroke if follow-up data are available.
90 days after stroke onset

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Minyoul Baik

Ermittler

  • Hauptermittler: Minyoul Baik, MD, Yongin Severance Hospital, Yonsei University College of Medicine

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. November 2026

Primärer Abschluss (Geschätzt)

1. Juni 2029

Studienabschluss (Geschätzt)

1. September 2029

Studienanmeldedaten

Zuerst eingereicht

13. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Oktober 2026

Zuerst gepostet (Tatsächlich)

29. Oktober 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • COMPASS-9-2026-0184
  • RS-2026-25581947 (Andere Zuschuss-/Finanzierungsnummer: National Research Foundation of Korea)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

There is no current plan to share individual participant data. Data sharing may be reconsidered in accordance with institutional policy and journal requirements.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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